Zafgen, a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, has announced that the company received a letter from the FDA placing a clinical hold on the Investigational New Drug Application (IND) for its first US clinical trial of ZGN-1061, the company’s second-generation, investigational MetAP2 inhibitor currently in development for the treatment of type 2 diabetes.

The FDA cited the possibility of cardiovascular (CV) safety risk based on the company’s prior compound and outlined multiple potential paths for moving forward, including nonclinical or clinical options, to address these concerns in the ongoing development of ZGN-1061. The company plans to assess these options and request a Type A meeting with the Agency to discuss next steps with the programme.

Zafgen continues to advance its ongoing ex-US Phase 2 clinical trial of ZGN-1061, which includes a 1.8mg dose cohort. Dosing in this clinical trial was recently completed and, while still blinded, no CV safety signals have been observed to date. The company remains on track to report top-line data from this cohort in early 2019. Zafgen previously reported positive full 12-week results for its initial cohort of this Phase 2 proof-of-concept clinical trial, which included a range of doses up to 0.9mg. In that initial cohort, ZGN-1061 met all primary endpoints, demonstrating proof-of-concept efficacy with robust A1C lowering effects, and a favourable safety and tolerability profile generally comparable to placebo, with no treatment-related serious adverse events and no CV safety signals observed.

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